Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2007-12-31

Brief Summary

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Randomized study in 2 arms, without any masking in patients with non small cell lung cancer, histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA, according to the TNM classification of the American Joint Committee for cancer. In one arm will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by concurrent radiotherapy with carboplatin-docetaxel

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Detailed Description

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Conditions

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Non Small-cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Docetaxel +Carboplatin +concomitant chemoradiation

Docetaxel 20 mg/m2/weekly plus carboplatin AUC 2/weekly (first, docetaxel will be administered and after that, carboplatin will be administered) and concomitant chemoradiation (total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks)

Group Type EXPERIMENTAL

Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day

Intervention Type DRUG

Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d

Intervention Type DRUG

C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom

Docetaxel 40 mg/ m2 days 1, 8, 21 y 28 plus gemcitabine 1200 mg/ m2 days 1, 8, 21 y 28 followed by concomitant treatment Docetaxel 20 mg/m2/week plus carboplatin AUC 2/weekly and concomitant chemoradiation total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks)

Group Type EXPERIMENTAL

Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day

Intervention Type DRUG

Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d

Intervention Type DRUG

Interventions

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Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day

Intervention Type DRUG

Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Unresectable stage IIIA or B NSCLC patients
* WHO PS 0 or 1
* Weight loss \< 5 % within the last 3 months
* At least one measurable lesion
* Planning CT scan previous to randomization
* Written informed consent